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Fase 2b undersøgelse, der evaluerer sikkerheden og effektiviteten af ​​AP01 hos deltagere med PPF

3. november 2026 opdateret af: Avalyn Pharma Inc.

Et randomiseret, dobbeltblindt, placebokontrolleret, fase 2b-studie, der evaluerer sikkerheden og effektiviteten af ​​Pirfenidon-opløsning til inhalation (AP01) hos deltagere med progressiv lungefibrose (PPF)

A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 (pirfenidone solution for inhalation) versus placebo on top of standard of care in participants with PPF over 52 weeks. Up to 300 eligible participants will be randomized to 1 of 3 treatment arms: AP01 high dose, AP01 low dose, or placebo.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

398

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
    • Buenos Aires
      • Buenos Aires, Buenos Aires, Argentina, 1427
        • Fundacion Respirar
      • Buenos Aires, Buenos Aires, Argentina, C1056AB
        • CINME
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1199ABH
        • Hospital Italiano de Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Instituto Ave Pulmo, Fundacion Enfisema
      • Monte Grande, Buenos Aires, Argentina, 1842
        • Clinica Monte Grande
      • Quilmes, Buenos Aires, Argentina, B1878
        • Centro Respiratorio Quilmes
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, 5003
        • Instituto de Medicina Respiratoria
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • CIMER Centro Integral de Medicina Respiratoria
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Investigaciones En Patologias Respiratorias
  • Australien
      • Canberra, Australien, 2605
        • Canberra Hospital
    • New South Wales
      • Camperdown, New South Wales, Australien, 2050
        • Royal Prince Alfred Hospital
      • Kingswood, New South Wales, Australien, 2745
        • Nepean Lung & Sleep
      • New Lambton, New South Wales, Australien, 2305
        • John Hunter Hospital
      • Sydney, New South Wales, Australien, 2109
        • Macquarie University Clinical Trials Unit
      • Westmead, New South Wales, Australien, 2145
        • Westmead Hospital
    • Perth West Australia
      • Nedlands, Perth West Australia, Australien, 6009
        • Institute for Respiratory Health
    • Queensland
      • Brisbane, Queensland, Australien, 4032
        • Wallace Street Specialist Centre/Lung Research QLD Pty Ltd
    • Victoria
      • Footscray, Victoria, Australien, 3011
        • Lung Research Victoria
      • Melbourne, Victoria, Australien, 3004
        • Alfred Health
  • Belgien
      • Leuven, Belgien, 3000
        • UZ Leuven
      • Liège, Belgien, 4000
        • CHU de Liège
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1M9
        • Vancouver General Hospital
    • Ontario
      • Ajax, Ontario, Canada, L1S2J5
        • Dynamic Drug Advancement
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Research Institute McGill University Health Center
      • Québec, Quebec, Canada, G1V4G5
        • Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
      • Trois-Rivières, Quebec, Canada, G8T7A1
        • CIC Mauricie
  • Det Forenede Kongerige
      • Cambridge, Det Forenede Kongerige, CB2 0BB
        • Royal Papworth Hospital
      • London, Det Forenede Kongerige, SW3 6HP
        • Royal Brompton Hospital
      • Manchester, Det Forenede Kongerige, M23 9LT
        • Manchester University NHS Foundation Trust
      • Nottingham, Det Forenede Kongerige, NG5 1PB
        • Nottingham University NHS Trust
      • Stoke-on-Trent, Det Forenede Kongerige, ST4 6QG
        • University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital
    • East Yorkshire
      • Cottingham, East Yorkshire, Det Forenede Kongerige, HU16 5JQ
        • Hull University Teaching Hospital NHS Trust
    • Heartlands
      • Birmingham, Heartlands, Det Forenede Kongerige, B95SS
        • Birmingham Heartlands Hospital
    • Leicester
      • Glenfield, Leicester, Det Forenede Kongerige, LE3 9QP
        • Leicester Biomedical Research Centre - Respiratory Theme
    • London
      • London, London, Det Forenede Kongerige, sw17 0QT
        • St George's University Hospitals NHS Foundation Trust
    • Midlands
      • Birmingham, Midlands, Det Forenede Kongerige, B15 2GW
        • ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme
    • Northern Ireland
      • Londonderry, Northern Ireland, Det Forenede Kongerige, BT46
        • C-TRIC Altnagelvin Hospital
    • Oxon
      • Oxford, Oxon, Det Forenede Kongerige, OX3 7LE
        • Oxford University Hospitals NHS Foundation Trust
    • South West
      • Exeter, South West, Det Forenede Kongerige, EX2 5DW
        • Royal Devon
    • West Midlands
      • Wolverhampton, West Midlands, Det Forenede Kongerige, WV10 0QP
        • The Royal Wolverhampton NHS Trust, New Cross Hospital, Research and Development
    • West Yorkshire
      • Leeds, West Yorkshire, Det Forenede Kongerige, LS9 7TF
        • St James University Hospital - LTHT
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35205
        • University of Alabama at Birmingham
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85259
        • Mayo Clinic- Scottsdale
    • California
      • Los Angeles, California, Forenede Stater, 90033
        • University of Southern California
      • Los Angeles, California, Forenede Stater, 90048
        • Cedars-Sinai
      • Los Angeles, California, Forenede Stater, 90095
        • UCLA
      • Newport Beach, California, Forenede Stater, 92663
        • Newport Native MD, Inc.
      • Redding, California, Forenede Stater, 96001
        • Paradigm Clinical Research - Redding
      • San Francisco, California, Forenede Stater, 94143
        • University of California - San Francisco
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • University of Colorado, Anschutz Medical Campus
      • Denver, Colorado, Forenede Stater, 80206
        • National Jewish Health
    • Connecticut
      • Farmington, Connecticut, Forenede Stater, 06030
        • UCONN Health
      • New Haven, Connecticut, Forenede Stater, 06519
        • Yale University
    • Florida
      • Leesburg, Florida, Forenede Stater, 34748
        • Clinical Site Partners, LCC
      • Ocala, Florida, Forenede Stater, 34470
        • Renstar Medical Research
      • Winter Park, Florida, Forenede Stater, 32789
        • Clinical Site Partners
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30309
        • Piedmont Healthcare, Inc.
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University
      • Evanston, Illinois, Forenede Stater, 60201
        • Endeavor Health
      • Maywood, Illinois, Forenede Stater, 60153
        • Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • The University of Kansas Medical Center
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • University of Maryland
      • Baltimore, Maryland, Forenede Stater, 21224
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • University of Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic Rochester
    • Missouri
      • Hannibal, Missouri, Forenede Stater, 63401
        • Hannibal Regional Healthcare System
    • New York
      • Mount Kisco, New York, Forenede Stater, 10549
        • Northern Westchester Hospital
      • Mount Kisco, New York, Forenede Stater, 10549
        • Northwell Health - Mount Kisco
      • New York, New York, Forenede Stater, 10032
        • Columbia University
      • New York, New York, Forenede Stater, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, Forenede Stater, 10021
        • Weill Cornell
      • New York, New York, Forenede Stater, 10017
        • NYU Langone Health
      • The Bronx, New York, Forenede Stater, 10467
        • Montefiore Medical Center
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University
      • Statesville, North Carolina, Forenede Stater, 28625
        • Piedmont HealthCare, PA
      • Wilmington, North Carolina, Forenede Stater, 28401
        • Accellacare
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Southeastern Research Center
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45267
        • University of Cincinnati
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic
    • Oregon
      • Beaverton, Oregon, Forenede Stater, 97008
        • The Oregon Clinic Pulmonary West
      • Bend, Oregon, Forenede Stater, 97701
        • Summit Health
      • Portland, Oregon, Forenede Stater, 97220
        • The Oregon Clinic Pulmonary East
      • Portland, Oregon, Forenede Stater, 97225
        • The Oregon Clinic Pulmonary West
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • The Pennsylvania State University
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, Forenede Stater, 19140
        • Temple University
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of South Carolina
      • Charleston, South Carolina, Forenede Stater, 29406
        • Lowcountry Lung and Critical Care
    • Tennessee
      • Franklin, Tennessee, Forenede Stater, 37067
        • Clinical Trials Center of Middle Tennessee
      • Nashville, Tennessee, Forenede Stater, 37204
        • Vanderbilt Lung Institute
    • Texas
      • Dallas, Texas, Forenede Stater, 75390
        • UT Southwestern Medical Center
      • Dallas, Texas, Forenede Stater, 75246
        • Baylor Scott & White Research Institute, Baylor University Medical Center
      • El Paso, Texas, Forenede Stater, 79902
        • El Paso Pulmonary Association
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine
      • Houston, Texas, Forenede Stater, 77030
        • The University of Texas Health Science Center
      • McKinney, Texas, Forenede Stater, 75069
        • Metroplex Pulmonary and Sleep Center, PA
    • Utah
      • Murray, Utah, Forenede Stater, 84157
        • Intermountain Medical Center
      • Salt Lake City, Utah, Forenede Stater, 84108
        • University of Utah Health
    • Virginia
      • Falls Church, Virginia, Forenede Stater, 22042
        • Inova Healthcare
    • Washington
      • Seattle, Washington, Forenede Stater, 98195
        • University of Washington
  • Frankrig
      • Angers, Frankrig, 49933
        • CHU Angers
      • Le Kremlin-Bicêtre, Frankrig, 94270
        • APHP - Hopital Bicetre
      • Paris, Frankrig, 75014
        • Hôpital Paris St Jozeph
      • Pessac, Frankrig, 33604
        • Hôpital Haut-Lévêque
    • Cedex NA
      • Rennes, Cedex NA, Frankrig, 35033
        • CHU de Rennes
    • Indre et Loire
      • Tours, Indre et Loire, Frankrig, 37000
        • CHU Tours
    • Lorraine
      • Metz, Lorraine, Frankrig, 57000
        • Robert Schuman Hospital UNEOS
    • Lyon
      • Lyon, Lyon, Frankrig, 69677
        • Louis Pradel Hospital
    • Montpellier
      • Montpellier, Montpellier, Frankrig, 34295
        • University of Montpellier
  • Holland
      • Rotterdam, Holland, 3015 GD
        • Erasmus University Medical Center
    • Utrecht
      • Nieuwegein, Utrecht, Holland, 3435
        • St Antoniusziekenhuis
  • Italien
    • Ancona
      • Torrette, Ancona, Italien, 60126
        • A.O.U. delle Marche - Ospedale di Torrette
    • Campania
      • Naples, Campania, Italien, 80131
        • Università degli Studi di Napoli Federico II - Ospedale Monaldi
      • Naples, Campania, Italien, 80131
        • Azienda Ospedaliera dei Colli - Ospedale Monaldi
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italien, 40138
        • IRCCS AOU di Bologna - Policlinico Sant' Orsola
    • Giulia
      • Venezia, Giulia, Italien, 34149
        • Azienda Sanitaria Universitaria Giuliano Isontina
    • Lombardy
      • Pavia, Lombardy, Italien, 27100
        • Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia
    • Milano
      • Milan, Milano, Italien, 20123
        • Ospedale San Giuseppe
      • Rozzano, Milano, Italien, 20089
        • HUMANITAS Research Hospital
    • Sicily
      • Catania, Sicily, Italien, 95123
        • A.O.U. Policlinico G. Rodolico
  • New Zealand
    • Auckland
      • Auckland, Auckland, New Zealand, 1051
        • Greenlane Clinical Centre
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8011
        • Health New Zealand
    • Dunedine
      • Dunedin, Dunedine, New Zealand, 9016
        • Dunedin Hospital
    • South Tauranga
      • Tauranga, South Tauranga, New Zealand, 3112
        • Bay of Plenty Clinical School
  • Polen
      • Lodz, Polen, 90-153
        • Department of Pneumology of the University Hospital No 1
      • Lodz, Polen, 90-602
        • PRYWATNY GABINET LEKARSKI GINEKOLOGIA I POŁOZNICTWO ULTRASONOGRAFIA Prof. Dr hab. Med. Jacek Suzin
    • Bydgoszc
      • Bydgoszcz, Bydgoszc, Polen, 85-079
        • Vitamed Galaj I Cichomski sp.j.
    • Krakow
      • Krakow, Krakow, Polen, 30-688
        • University Hospital in Krakow
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Polen, 90-349
        • AppleTreeClinics Network
  • Spanien
      • Barcelona, Spanien, 08908
        • Hospital Universitary de Bellvitge
      • Cadiz, Spanien, 11009
        • Hospital Universitario Puerta del Mar - Leon-Jimenez
    • Andalusia
      • Granada, Andalusia, Spanien, 18014
        • Hospital Universitario Virgen de las Nieves
    • Barcelona
      • Barcelona, Barcelona, Spanien, 08025
        • Hospital de Sant Pau y la Santa Creu
    • Cantabria
      • Santander, Cantabria, Spanien, 39008
        • Hospital Universitario Marqués de Valdecilla
    • Madrid
      • Madrid, Madrid, Spanien, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Madrid, Spanien, 28007
        • Hospital Gregorio Marañon
    • Málaga
      • Málaga, Málaga, Spanien, 29010
        • Hospital Universitario Virgen de la Victoria
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spanien, 33011
        • Hospital Universitario Central de Asturias
    • Sevilla
      • Seville, Sevilla, Spanien, 41013
        • Hospital Universitario Virgen del Rocío
  • Tyrkiet (Türkiye)
      • Adana, Tyrkiet (Türkiye), 01240
        • Cukurova University Medical Faculty
      • Ankara, Tyrkiet (Türkiye), 06010
        • Health Sciences University, Gulhane Faculty of Medicine
    • İzmir
      • Bornova, İzmir, Tyrkiet (Türkiye), 35100
        • Ege University Medical Faculty Hospital
  • Tyskland
    • Bavaria
      • Munich, Bavaria, Tyskland, 81241
        • Pneumologisches Studienzentrum München-West
      • München, Bavaria, Tyskland, 81925
        • Muenchen Klinik Bogenhausen - Klinik für Pneumologie und Pneumologische Onkologie
      • Rosenheim, Bavaria, Tyskland, 83022
        • RoMed Klinikum Rosenheim
    • Lower Saxony
      • Hanover, Lower Saxony, Tyskland, 30625
        • Medizinische Hochschule Hannover
    • Main Hessia
      • Frankfurt, Main Hessia, Tyskland, 60389
        • Studienzentrum Dr. Claus Keller
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Tyskland, 45239
        • Ruhrlandklinik Essen, Klinik fuer Pneumologie
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Tyskland, 55131
        • Universitätsmedizin Mainz - Zentrum für Thoraxerkrankungen
    • Saxony
      • Leipzig, Saxony, Tyskland, 04103
        • Uniklinikum Leipzig Medizinische Klinik II - Bereich
    • State of Berlin
      • Berlin, State of Berlin, Tyskland, 12351
        • Vivantes Klinikum Neukölln - Klinik für Innere Medizin - Pneumologie und Infektiologie

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Participant meets criteria for PPF, as follows:
  • In subjects with interstitial lung disease (ILD) of known or unknown etiology other than idiopathic pulmonary fibrosis (IPF) who have radiological evidence of pulmonary fibrosis, PPF is defined as:

Physiological evidence of disease progression with at least 1 of the following criteria despite treatment with approved or unapproved medications commonly used in practice (per Investigator):

  1. Relative decline in FVC ≥10% predicted within the previous 24 months based on documented historical spirometry assessments

  2. Relative decline in FVC ≥5% to <10% predicted within the previous 24 months based on documented historical spirometry assessments with at least 1 of the 2 following criteria:

    • Worsening respiratory symptoms (Note: Changes attributable to comorbidities e.g., infection, heart failure must be excluded) OR

    • Radiological (HRCT) evidence of disease progression per a local or central radiologist (from historical HRCT taken up to 24 months prior to Screening Visit 1), for example:

      • Increased extent or severity of traction bronchiectasis and bronchiolectasis
      • New ground-glass opacity with traction bronchiectasis
      • New fine reticulation
      • Increased extent or increased coarseness of reticular abnormality
      • New or increased honeycombing
      • Increased lobar volume loss

  3. Worsening of respiratory symptoms (Note: Changes attributable to comorbidities e.g., infection, heart failure must be excluded) AND radiological (HRCT) evidence of disease progression per a local or central radiologist

    • Meeting all of the following criteria during the Screening Period:

a. FVC ≥45% of predicted normal at Screening Visit 1, b. Forced expiratory volume at 1 second (FEV1)/FVC ≥0.7 or ≥age-adjusted lower limit of normal at Screening Visit 1, c. Diffusing capacity of lung for carbon monoxide (DLCO) ≥30% of predicted, corrected for hemoglobin at Screening Visit 1, d. Acceptability: Participants can perform acceptable spirometry (i.e., meet American Thoracic Society (ATS)/ European Respiratory Society (ERS) acceptability criteria at both Screening Visits).

• For subjects already on background therapy (nintedanib or nerandomilast 18 mg twice daily [up to 30% of subjects]): Must have been on background therapy for at least 12 weeks prior to Screening with or without dose adjustments and/or drug interruptions during that period. For subjects who have discontinued background therapy prior to Screening: Must have been off for a minimum of 12 weeks.

Exclusion Criteria:

  • Current treatment with oral pirfenidone or nerandomilast 9 mg twice daily dose or treatment with oral pirfenidone within 3 months prior to Screening.

  • Elevated liver enzymes and liver injury at Screening defined as:

    1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ˃ 3 times the upper limit of normal (ULN)
    2. Bilirubin >2.0 x ULN

  • Renal disease with a creatinine clearance < 30 mL/min, calculated according to the Chronic Kidney Disease Epidemiology Collaboration formula. Retesting is allowed once.

  • Diagnosis of idiopathic pulmonary fibrosis (IPF) based on the ATS diagnostic algorithm for IPF. UIP that is not idiopathic, for example related to rheumatoid arthritis (RA), familial interstitial lung disease (ILD), or other is not exclusionary.

  • Greater extent of emphysema than of fibrotic ILD on HRCT. Note: CT results must be confirmed through the central over read process.

  • Significant clinical worsening of PPF between Screening Visit 1 and Visit 3

  • Participants who cannot meet protocol-specified Baseline stability criteria. FVC Baseline stability is defined as the FVC assessments at Visit 3 being within ±12% of the mean of the FVC assessments obtained at the 2 preceding visits. At Visit 3, if the pre-dose FVC is outside of ±12% range, the participant will not be randomized and will be considered a screen failure.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: AP01 High Dose BID

Pirfenidone Solution for Inhalation
Medicin: AP01

Oral inhalation solution

Andre navne:
  • Pirfenidonopløsning
Eksperimentel: AP01 Low Dose BID

Pirfenidone Solution for Inhalation
Medicin: AP01

Oral inhalation solution

Andre navne:
  • Pirfenidonopløsning
Placebo komparator: Placebo BID

Placebo solution for inhalation
Andet: Placebo

Placebo oral inhalation solution

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To evaluate the effect of AP01 high dose twice a day (BID) or AP01 low dose twice a day (BID) compared to placebo twice a day (BID)
Tidsramme: Week 52

Change from baseline in forced vital capacity (FVC) (mL)
Week 52

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To evaluate the effect of AP01 high dose and AP01 low dose compared to placebo on disease progression (defined as absolute FVC percent predicted decline of ≥10% prior to Week 52)
Tidsramme: 52 weeks

Time to disease progression
52 weeks
To evaluate the effect of AP01 high dose, AP01 low dose compared to placebo on quality of life (QoL)
Tidsramme: 52 weeks

Absolute change from Baseline in QoL measurements as assessed by Living with Pulmonary Fibrosis Symptoms and Impact Questionnaire (L-PF) total score. The L-PF is a 44-item questionnaire to assess how impacted a participant is by disease symptoms on a scale from 0 (Not at all) to 4 (Extremely). The higher the summary score, the greater the impairment.
52 weeks
To evaluate the change from baseline in quantitative lung fibrosis score.
Tidsramme: 52 weeks

Change in lung fibrosis score.
52 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To evaluate the safety of AP01 high dose and AP01 low dose compared to placebo
Tidsramme: 52 weeks

Incidents of adverse events (AEs), serious adverse events (SAEs), and treatment-emergent deaths
52 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Avalyn Pharma Inc.

Samarbejdspartnere

DevPro Biopharma

Efterforskere

  • Studieleder: Avalyn Pharma, Inc., Avalyn Pharma Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. april 2024

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

12. marts 2024

Først indsendt, der opfyldte QC-kriterier

19. marts 2024

Først opslået (Faktiske)

25. marts 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AP01-007

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner